BEUDAMED
    FDA Registration Active 🇺🇸 United States

    O-Arm Imaging System

    Reg #: 3004785967 · FEI: 3004785967 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MEDTRONIC NAVIGATION, INC. (Boxborough)
    Registration Number
    3004785967
    FEI Number
    3004785967
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    200 Beaver Brook Rd
    City
    Boxborough
    State
    MA
    ZIP
    01719
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050996

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO

    Proprietary Names

    O-Arm Imaging System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Remanufacture Medical Device